Status:
TERMINATED
[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
FutureChem
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of \[18F\]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostat...
Detailed Description
This research is being done to determine whether the radioactive compound called \[18F\]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer. Participants in this study...
Eligibility Criteria
Inclusion
- Males ≥18 years of age.
- Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Histologically confirmed adenocarcinoma of the prostate.
- Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day 1.
- At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease
- Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator.
Exclusion
- Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
- Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04528199
Start Date
February 1 2021
End Date
April 21 2023
Last Update
January 16 2024
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287